It has become well established that there are major health benefits from regular endoscopic examinations of a patient's internal structures such as the alimentary canals and airways, e.g., the esophagus, stomach, lungs, colon, uterus, urethra, kidney, and other organ systems. Endoscopes are also commonly used to perform surgical, therapeutic, diagnostic, or other medical procedures under direct visualization. A conventional imaging endoscope used for such procedures includes an illuminating mechanism such as a fiber optic light guide connected to a proximal source of light, and an imaging means such as an imaging light guide to carry an image to a remote camera, or eye piece, or a miniature video camera within the endoscope itself. In addition, most endoscopes include one or more working channels through which medical devices such as biopsy forceps, snares, fulgration probes, and other tools may be passed in order to perform a procedure at a desired location in the patient's body.
At the proximal end of the endoscope is a handle that includes steering controls and other actuators that allow a user to control the orientation and operation of the endoscope. The endoscope is guided through the patient's tract or canal until an opening at or adjacent the distal end of the endoscope is proximate to the area of the patient's body which is to be examined or receive treatment. At this point, the endoscope allows other tools, such as a catheter or biopsy forceps, to access the targeted area.
Conventional endoscopes are expensive, hand assembled, medical devices costing in the range of $25,000 for an endoscope, and much more for the associated operator console. Because of this expense, these conventional endoscopes are built to withstand repeated disinfections and use upon many patients. Conventional endoscopes are generally built of sturdy materials, which decreases the flexibility of the scope and thus can decrease patient comfort. Furthermore, conventional endoscopes are complex and fragile instruments that frequently need expensive repair as a result of damage during use or during a disinfection procedure.
Low cost, disposable medical devices designated for a single use have become popular for instruments that are difficult to clean properly. Single-use, disposable devices are packaged in sterile wrappers to avoid the risk of pathogenic cross-contamination of diseases such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use disposable products because they no longer have to be concerned with product age, overuse, breakage, malfunction, and sterilization. One medical device that has not previously been inexpensive enough to be considered truly disposable is the endoscope, such as a colonoscope, bronchoscope, gastroscope, duodenoscope, etc. Such a single-use or disposable endoscope is described in U.S. patent application Ser. No. 10/811,781, filed Mar. 29, 2004, and in a U.S. Continuation-in-Part patent application Ser. No. 10/956,007, filed Sep. 30, 2004, that are assigned to Scimed Life Systems, Inc., now Boston Scientific Scimed, Inc., and are hereby incorporated by reference.
Biopsies are often performed using an endoscope to determine whether a tumor is malignant or to determine the cause of an unexplained inflammation. For example, a gastrointestinal biopsy is typically performed through a flexible endoscope. The endoscope is guided by an operator to the desired location in the body and a tool is inserted through a lumen to the biopsy site. While viewing the biopsy site through the optical lens of the endoscope, an operator manipulates an actuating handle to effect a tissue sampling. After a sample has been obtained, the operator then carefully withdraws the biopsy tool from the endoscope while holding the actuating handle to maintain the jaws in a closed position. The above described endoscopic biopsy procedure generally requires two or three people, including the operator controlling the endoscope, and one or more assistants to actuate the biopsy forceps, withdraw the tissue specimen, place the specimen into a sterile container with a label, and send the container to pathology for analysis.
The process of taking a biopsy presents several challenges, including accurate targeting of the biopsy site, precise and accurate penetration of the biopsy site, preservation of the biopsy tissue upon extraction, and tracking the source of the biopsy sample. Multiple biopsies are often required in order to obtain an accurate diagnosis of malignant tumors, inflammatory conditions, and infectious processes and are also used to improve the diagnostic yield of tissue for later analysis. Multiple biopsies during a single clinical procedure amplify the above-mentioned challenges.
To obtain multiple samples with a conventional biopsy system, biopsy tools must be repeatedly inserted and the sample retrieved, thereby compounding the already awkward procedure. In addition, conventional biopsy systems are not equipped with a sample retrieval device for receiving and cataloging multiple samples, and such systems do not provide a method by which the precise location of the biopsy site can be tracked and correlated with the biopsy sample.